BioWare for AUD and PTSD

Not Applicable

Completed

• Conditions: PTSD; Alcohol Use Disorder
• Interventions: Behavioral: COPE

• Registration Number: NCT05187364
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-11
• Study Start: 2022-05-05
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Male or female; aged 18-70 years.
2. Able to provide written informed consent.
3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
4. Meet DSM-5 diagnostic criteria for current PTSD.
5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria

1. Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
2. Current suicidal or homicidal ideation and intent.
3. Psychotropic medications which have been initiated during the past 4 weeks.
4. Acute alcohol withdrawal.
5. Pregnancy or breastfeeding for people of childbearing potential.
6. Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
7. Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPE Therapy Arm	COPE	Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less	In-Session Visit (approximately 1 week from baseline)	Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
System Usability Scale	Week 12	The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States